Using acupuncture to manage pain in sickle cell disease

Integrative Medicine in Pain Management in Sickle Cell Disease: Assessing the Clinical Efficacy and Neurobiological Impact With Acupuncture

This study is testing whether acupuncture can help people with sickle cell disease manage their pain better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 14 Years to 80 Years
• Sex: All
• Sponsor: Indiana University (other)
• Drugs / interventions: Crizanlizumab
• Locations: 1 site (Indianapolis, Indiana)
• Trial ID: NCT05045820 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate the effectiveness and underlying neurobiological mechanisms of acupuncture as a pain management technique for patients with sickle cell disease. Participants will be randomly assigned to receive either traditional acupuncture or laser acupuncture over 10 sessions, with assessments of pain and sensory functionality conducted before and after treatment. The study will also utilize magnetic resonance imaging to observe brain activity related to pain perception. In total, participants will attend 14 visits over approximately 6-8 weeks, followed by 12 months of follow-up.

Who should consider this trial

Good fit: Ideal candidates include adolescents and adults aged 14-80 diagnosed with sickle cell disease who experience chronic pain or vaso-occlusive crises.

Not a fit: Patients who are not experiencing chronic pain or have not had a vaso-occlusive crisis in the past year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-opioid alternative for pain management in patients with sickle cell disease.

How similar studies have performed: Previous studies have shown promising results for acupuncture in pain management, suggesting potential success for this approach in sickle cell disease.

Eligibility criteria

Inclusion Criteria:

* Any gender
* 14-17 (Adolescents) and 18-80 (Adults) years old
* Right-handed
* Either outpatient or inpatient or status changing between each other
* Have been diagnosed with SCD (includes but not limited to SS, SC or other type) and experiencing chronic pain in the past 6 months or vaso-occlusive crisis (VOC) in the past 12 months.
* Analgesic therapy prescribed by primary hematologists (or physicians for emergency or primary care) including pain-relieving medications (e.g. Morphine, coderin, Fentanyl, Oxycodone), Hydroxyurea (e.g. Droxia, Hydrea, Siklos), L-glutamine oral powder (Endari), Crizanlizumab (Adakveo), Voxelotor (Oxbryta), and/or other palliative treatment allowed, not required.
* Willing to limit the current and the introduction of any new medications or treatment modalities for control of pain symptoms during the study visits.
* Able to travel to the study site for participating scheduled visits (questionnaires, QST, EEG and MRI) and receive acupuncture treatments up to two times weekly for 5 weeks as scheduled.
* We will recruit without regard to ethnicity, however, due to the genetic nature of SCD, subjects will primarily be African-American or of African descent, although there are individuals with SCD who come from Hispanic, southern European, Middle Eastern, or Asian Indian backgrounds. The ethnic distribution in our prior studies is 95% Black/African American with 5% Hispanic or Latino (of any race). As these are minority groups many individuals may be from lower income situations.
* Fluent in English and capable of giving written informed consent.

Exclusion Criteria:

* Subjects with Covid-19 suspicion or confirmation
* Recent/ongoing alternative pain management with acupuncture or acupuncture-related techniques within the last 6-months.
* Presence of a known coagulation abnormality: Thrombocytopenia (mild thrombocytopenia with a platelets range of 51,000-100,000/ul will be further evaluated for inclusion consideration), or bleeding diathesis that may preclude the safe use of acupuncture.
* Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain or any other chronic pain condition with pain greater than sickle pain.
* Diseases/conditions history includes but not limited to:

  * head injury with substantial loss of consciousness
  * peripheral neuropathy of known cause that interferes with activities of daily living
  * known non-SCD related Severe psychiatric illnesses (e.g. current schizophrenia, major depression with suicidal ideation).
  * significant visual, motor, or auditory impairment that would interfere with ability to perform study visits-related activities
* Medication:

Recent (30 days) initiation or dose adjustment of stimulant medications, such as those used to treat ADD/ADHD (e.g., amphetamine/dextroamphetamine \[Adderall®\], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil).

* Contraindications to MRI scans includes but are not limited to: surgical clips, surgical staples, metal implants, cardiac rhythmic disorders, seizure disorders, and certain metallic dental material will not be scheduled for MRI visits.
* History vascular surgery in lower limbs or current lower limb vascular dysfunction will not receive conditioned pressure pain stimuli in the lower limb.
* Subjects with Worker's Compensation, Workman's Compensation, civil litigation or disability claims pertinent to the subject's sickle disease; current involvement in out-of-court settlements for claims pertinent to the subject's sickle disease; or currently receiving monetary compensation as a result of any of the above.
* Participation of other studies: Concurrent participation in other therapeutic trials with overlapping research purposes.
* Pregnant or nursing.

Where this trial is running

Indianapolis, Indiana

• Indiana University School of Medicine — Indianapolis, Indiana, United States (RECRUITING)

Study contacts

• Study coordinator: Ying Wang, MD, PhD

Conditions: Sickle Cell Disease, Pain, Acupuncture, Quantitative Sensory Testing, Magnetic Resonance Imaging, Circulating Biomarkers, Electroencephalography, Functional Near-infrared Spectroscopy